FDA 510(k)

山貓融合AdV/hMPV/RV檢測試劑

K 號：K231017 · 2023-05-05

決定日期2023-05-05

產品代碼OCC

諮詢委員會MI (請提供完整的描述文本，以便進行翻譯。)

決定相當於

器材摘要

Panther Fusion AdV/hMPV/RV Assay is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2023-05-05 under 510(k) number K231017. The device is classified under product code OCC. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Panther Fusion AdV/hMPV/RV Assay?

Panther Fusion AdV/hMPV/RV Assay is a medical device that received FDA 510(k) clearance on 2023-05-05. The listed applicant is Hologic, Inc.. The 510(k) number is K231017.

When did Panther Fusion AdV/hMPV/RV Assay receive FDA 510(k) clearance?

Panther Fusion AdV/hMPV/RV Assay received FDA 510(k) clearance on 2023-05-05, under 510(k) number K231017.

Who is the listed applicant for Panther Fusion AdV/hMPV/RV Assay?

FDA 510(k) 記錄將霍洛基克公司（Hologic, Inc.）列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Panther Fusion AdV/hMPV/RV Assay?

The FDA product code for Panther Fusion AdV/hMPV/RV Assay is OCC.

其他以 Hologic, Inc. 為申請人之記錄

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官方來源

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